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adicciones vol.27, issue1 2015

Smoking cessation after 12 months


with multi-component therapy
Abstinencia a los 12 meses de un programa
multicomponente para dejar de fumar
Antnia Raich*,**** ; Jose Maria Martnez-Snchez**,***; Emili Marquilles*; Ldia Rubio*;
Marcela Fu**; Esteve Fernndez**,****
*Unidad de Tabaquismo (Smoking Cessation Unit), Althaia Xarxa Assistencial Universitria de Manresa FP. **Unidad
de Control del Tabaquismo (Smoking Control Unit), Institut Catal dOncologia (Catalonian Institute of Cancer) (ICOIDIBELL). ***Unidad de Bioestadstica (Biostatistics Unit), Departamento de Ciencias Bsicas (Dept. of Basic Sciences),
Universitat Internacional de Catalunya, Sant Cugat del Valls. ****Departamento de Ciencias Clnicas (Dept. of Clinical
Sciences), Campus de Bellvitge, Facultat de Medicina, Universitat de Barcelona.

Abstract

Resumen

Smoking is one of the most important causes of morbidity and

El tabaquismo es una de las causas de morbimortalidad ms

mortality in developed countries. One of the priorities of public health

importantes en los pases desarrollados. Uno de los objetivos

programmes is the reduction of its prevalence, which would involve

prioritarios de los programas de salud pblica es la disminucin de su

millions of people quitting smoking, but cessation programs often

prevalencia lo que implica que millones de personas dejen de fumar,

have modest results, especially within certain population groups. The

sin embargo los programas de cesacin a menudo tienen resultados

aim of this study was to analyze the variables determining the success

discretos, especialmente con algunos grupos de poblacin. El objetivo

of a multicomponent therapy programme for smoking cessation. We

de este estudio fue analizar la eficacia de un tratamiento de cesacin

conducted the study in the Smoking Addiction Unit at the Hospital

tabquica multicomponente realizado en una unidad de tabaquismo

of Manresa, with 314 patients (91.4% of whom had medium or

hospitalaria. Fue realizado en la Unidad de Tabaquismo del Hospital

high-level dependency). We observed that higher educational level,

de Manresa, e incluy 314 pacientes (91,4% presentaban un nivel de

not living with a smoker, following a multimodal programme for

dependencia medio o alto). Se observ que el nivel de estudios, no

smoking cessation with psychological therapy, and pharmacological

convivir con fumadores, seguir la terapia multicomponente y utilizar

treatment are relevant factors for quitting smoking. Abstinence

tratamiento farmacolgico son factores relevantes en el xito al dejar

rates are not associated with other factors, such as sex, age, smoking

de fumar. La tasa de abstinencia no se asocia con otras caractersticas

behaviour characteristics or psychiatric history. The combination of

como el sexo, la edad, las caractersticas del hbito tabquico o el

pharmacological and psychological treatment increased success rates

presentar antecedentes psiquitricos. La combinacin del tratamiento

in multicomponent therapy. Psychological therapy only also obtained

farmacolgico y psicolgico aument las tasas de xito en la terapia

positive results, though somewhat more modest.

multicomponente. La terapia psicolgica nica tambin obtuvo

Key words: multimodal treatment, smoking cessation, mental disorders,

resultados positivos aunque ms modestos.

heavy smokers.

Palabras clave: tratamiento multicomponente, deshabituacin tab


quica, trastornos mentales, pacientes con alta dependencia.

Received: June 2014; Accepted: October 2014


Address for correspondence:
Antnia Raich. Unidad de Tabaquismo. Althaia Xarxa Assistencial Universitria de Manresa FP. C/Dr. Llatjs, 6-8, edifici CSAM. 08243
Manresa. E-mail: araich@althaia.cat
ADICCIONES, 2015 VOL. 27 ISSUE 1 PAGES 37-46

37

Smoking cessation after 12 months with multi-component therapy

Method

mong the most challenging aspects involved in


interventions with smokers are the chronicity of
this addiction and the apparent limitations of
programmes designed to help people quit smoking. In order to design interventions with maximal levels of
efficiency, it is of the utmost importance to consider previous
studies that can contribute data for analyzing the conditions
and characteristics of efficacious treatments, the predictors
of good results, the characteristics of participants and their
success or failure in smoking cessation programmes.
There are a range of different types of smoking cessation
interventions: brief advice from a health professional (the
person is advised and encouraged to give up smoking), self-help
courses and materials, the prescription of pharmacological
treatments with or without follow-up, motivational
interventions, and multicomponent therapy (Hays, Ebbert, &
Sood 2009; Hays, Leischow, Lawrence, & Lee 2010; Stead &
Lancaster 2012). The last in this list may be the most intensive
of such interventions, since it combines psychological and
pharmacological interventions of proven efficacy. The results
of smoking cessation treatments currently available are modest:
the most efficacious have achieved no more than 30-40%
abstinence rates at the one-year follow-up (Ranney, Melvin,
Lux, McClain, & Lohr, 2006) in general population.
Pharmacological treatment and smoking cessation advice
have been widely analyzed in the scientific literature, and the
majority of studies concur that they increase the likelihood
of success in quitting smoking (PHS Guideline Update
Panel, Liaisons, and Staff, 2008; Silagy, Lancaster, Stead,
Mant, & Fowler, 2004; Wilkes, 2008). Various studies have
shown that sociodemographic variables (sex, educational
level, socioeconomic level) influence the results, as well
as the characteristics of the smoking addiction and the
persons health antecedents (Nerin, Novella, Beamonte,
Gargallo, Jimenez-Muro, & Marqueta, 2007; Ramon &
Bruguera, 2009). However, there is scarcely any research
analyzing these aspects in multicomponent therapy, whose
efficacy has indeed been studied, but not the influence on it
of these variables (Bauld, Bell, McCullough, Richardson, &
Greaves, 2010; Hays et al., 2009).
Addictive disorders are complex entities that affect
human behaviour with physiological, psychological and
sociological bases. The comprehensive approach involved
in multicomponent therapy is that which has yielded
the best outcomes in the medium and long term (PHS
Guideline Update Panel, 2008; Alonso-Perez, AlonsoCardeoso, Garcia-Gonzalez, Fraile-Cobos, Lobo-Llorente,
& Secades-Villa, 2013; Stead & Lancaster 2005). Thus, the
aim of the present study was to analyze the efficacy of a
multicomponent smoking cessation treatment carried out
in a hospital Smoking Addiction Unit and how its outcomes
were influenced by the characteristics of participants and
their addiction, social factors, different pharmacological
treatments, and psychological therapy.

Design and participants


Longitudinal study of 314 patients who attended the
Smoking Addiction Unit at the Hospital de Manresa
(Manresa, Spain) to try and quite smoking between January
2001 and December 2009. This unit takes in patients
referred from other departments in the same hospital
or from primary care services, where all have received
brief interventions for smoking cessation, and more than
65% have received specific interventions that have failed
(carried out by specialist nurses working in primary care,
cardiology units, pulmonary units, etc.). Included in the
study were all those patients treated in the unit that followed
multicomponent therapy; inclusion was in accordance
with order of registration on the waiting list, where they
remained for an average of nine months. Exclusion criteria
for the multicomponent treatment were: psychiatric illness
in an acute phase or a psychotic disorder, reading and/or
writing problems, and other disorders that would make it
difficult to follow the therapy. The majority of the patients
referred to this programme were from the central area of
Catalonia (Manresa and the surrounding area).

Procedure
A one-year follow-up was carried out, counting from the
point at which the patient gave up or should have given
up smoking, which for the patients meant a mean of 14
months of therapy. A total of 90% of the patients received
the multicomponent therapy in group format, while just
10% did so on an individual basis. The structure of the
therapy was the same for the group and individual formats.
In principle, all patients were assigned to the group mode,
the individual format being employed only in exceptional
cases (pregnant patients who could not wait for the start of
group programme, or people with difficulties for following
the group timetable). The therapy was implemented by the
same professionals (a psychologist and a lung specialist)
throughout the study. The multicomponent treatment
programme brings together all those strategies that have
shown themselves to be efficacious (Alonso-Perez et al.,
2014; Fiore, Jaen, Baker, Bailey, Benowitz, & Curri, 2009):
psychological treatments based on behavioural, cognitive,
motivational and relapse prevention techniques combined
with pharmacological treatment based on nicotine
replacement (Becoa & Mguez, 2008; Ranney et al.,
2006), bupropion and varenicline (Wu, Wilson, Dimoulas,
& Mills, 2006; Tinich & Sadler 2007; Cahill, Stevens, &
Lancaster 2014). Multicomponent therapy consists of three
phases: a) preparation, which involves psychoeducation
about addiction, motivation to quit, changing habits,
and monitoring of tobacco use with or without reduction
in six weekly 75-minte sessions; b) cessation, in which
pharmacological treatment is introduced where applicable

ADICCIONES, 2015 VOL. 27 ISSUE 1

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Antnia Raich, Jose Maria Martnez-Snchez, Emili Marquilles, Ldia Rubio, Marcela Fu and Esteve Fernndez

in person at the hospital or by telephone for the follow-up


(months 1, 3, 6 and 12) and all the relevant information
recorded. All the patients who claimed to remain abstinent
were given an appointment to take a carbon monoxide test.

and the therapists work on coping with the day the patient
gives up (D-Day), withdrawal syndrome and craving,
in four two-weekly 60-minute sessions; and c) relapse
prevention, following the models of Marlatt, Curry and
Gordon (1988) and Baer and Marlatt (1991), in 10 monthly
60-minute sessions.
The therapy involved no direct financial cost for the
patients, except for the pharmacological treatment, for
which they had to pay. All the patients received the same
psychological therapy and assignment to one type of
pharmacological treatment or another was in line with
clinical criteria, taking into account at each moment the
treatment that could most benefit the patient in accordance
with availability, previous experience, personal health
antecedents and pharmacological interactions with other
treatments he or she might be undergoing at that time.
Some patients decided not to take up the treatment, and
this group also includes those who did not receive treatment
because they dropped out of the programme before
beginning it (n=69).
Those patients that did not take up the treatment for
whatever reason remained in the study, and were contacted
by telephone or personally for the purpose of obtaining the
necessary follow-up data. The distribution of the patients
across the different treatment modes and retention up to
the 12-month follow-up are shown in detail in Figure 1.
Information on sociodemographic variables, heath
antecedents and smoking characteristics were obtained at
the first visit (which was always individual) based on the
patient interview and the data from the persons clinical
records. Information on how the patient was developing
and the drugs used was recorded in the first, third, sixth and
twelfth month after D-Day. All patients were contacted

Instruments
The objective measure of abstinence used was level of
carbon monoxide (CO) in expired air, or co-oximetry
(abstinent if CO6ppm) (Middleton & Morice, 2000). The
instrument employed for this purpose was a co-oximeter
(Bedfont Pico Smokerlyzer).
For the data analysis, the following variables were taken
into account: sex, age, educational level, living with other
smokers or not, occupation, number of cigarettes smoked
per day, years smoked, level of dependence according to
Fagerstrm Test (low dependence 4; medium=5; high 6),
psychiatric antecedents (yes/no), multicomponent therapy
(yes/no), pharmacological treatment (yes/no), and drug
used for smoking cessation.

Statistical analysis
The categorical variables are shown as absolute value
and relative frequency. The continuous variables are shown
with the mean and standard deviation. We calculated the
accumulated incidence of abstinence, both global and
according to multicomponent programme, at 1, 3, 6 and
12 months, together with its 95% confidence interval. The
variables associated with relapse at 12 months were examined
using bivariate and multivariate logistic regression models.
In the multivariate logistic regression model we introduced
the covariables found to be significant in the bivariate
analysis, or with evidence of their association. We used a
stepwise exclusion strategy controlled by the researcher. The

Baseline visit
N=314

Dropped out before starting programme


N=69

Multicomponent programme
N=245

Psychological treatment
N=81

Abstinent
N=1

Not abstinent
N=68

Abstinent
N=13

Not abstinent
N=68

Figure 1. Patient flow

ADICCIONES, 2015 VOL. 27 ISSUE 1

39

Psychological and pharmacological


treatment
N=164

Abstinent
N=61

Not abstinent
N=103

Smoking cessation after 12 months with multi-component therapy

received psychological therapy only, with a rate of 16%, and


those who received no type of treatment (1.4%) (Table 2).
In the bivariate analysis, sex, age, years smoked,
dependence (score on Fagerstrm Test) and psychiatric
antecedents, did not appear as relapse risk factors. A trend
towards significance was observed, with higher relapse rate,
among younger patients (OR 0.98) and those who had
been smoking for 20 years or less (OR 1.96). Having at least

raw and adjusted odds ratios (OR) and the 95% confidence
intervals (CI 95%) were calculated. Statistical significance
level was bilateral 5% (p<0.05).
The programs used in the statistical analysis were IBM
SPSS Statistics for Windows v.22 (IBM Corporation,
Armonk, New York, USA) and Stata v.10 (StataCorp LP,
College Station, Texas, USA).

Results

Table 1.
Baseline characteristics of participants (n=314)

Mean age of the patients was 48.5 years; 61.8% were men,
61.9% had only elementary education and 32.6% were skilled
workers or professionals. As regards smoking characteristics,
50.3% lived with other smokers, 34.4% had been smoking
for 35 years or more, 48.2% smoked 21 or more cigarettes
per day, and 68.8% had high nicotine dependence (score
6) according to the Fagerstrm Test. Furthermore, 57.1%
of the patients had made two or more previous attempts to
quit smoking, 85% had been referred to the programme
from other hospital departments where they were being
treated for illnesses associated with smoking, and 58% had
psychiatric antecedents (Table 1).
Of the total 314 patients, we included all those who during
the studied period put their names down on the waiting list
and came to the first appointment when called; of these, 69
dropped out of the programme before the first session of
multicomponent therapy and the remaining 245 began the
multicomponent therapy (Figure 1). Of these 245 patients,
81 did not receive the pharmacological treatment, on their
own or the doctors decision (n=29) or because they gave up
the therapy before completing the first phase (n=52).
Abstinence for the whole sample was 50.3% at the onemonth follow-up, 38.5% at three months, 29.0% at six
months and 23.9% at 12 months. Patients who received
psychological and pharmacological treatment obtained the
highest abstinence rates at all the follow-up points, showing an
abstinence rate at 12 months of 37.2%, followed by those who

n=(%)
Mean age [standard deviation]

48,5[12,1]

Sex
Man
Woman

194 (61,8)
120 (38,2)

Educational level
Primary
Secondary
University

192 (61,9)
63 (20,3)
55 (17,7)

Living with smokers


No
Yes

156 (49,7)
158 (50,3)

Years smoked
20
21-35
> 35

68 (21,7)
138 (43,9)
108 (34,4)

Fagerstrm Test
< 4 Low
4-5 Medium
6 High

27 (8,6)
71 (22,6)
216 (68,8)

Psychiatric antecedents
No
Yes

132 (42,0)
182 (58,0)

Multicomponent programme
Neither psychological nor pharmacological
treatment
Psychological treatment
Psychological and pharmacological treatment

69 (22,0)
81 (25,8)
164 (52,2)

Nicotine replacement therapy


Bupropion
Varenicline

84 (51,2)
30 (18,3)
50 (30,5)

Table 2.
Abstinence (global and according to multicomponent programme) at 1, 3, 6 and 12 months
n

1 montha

3 monthsa

6 monthsa

12 monthsa

314

50,3 (44,6-56,0)

38,5 (33,1-44,2)

29,0 (24,0-34,3)

23,9 (19,3-29,0)

Neither psychological nor pharmacological treatment

69

2,9 (0,4-10,1)

1,4 (0,04 -7,8)

1,4 (0,04 -7,8)

1,4 (0,04 -7,8)

Psychological treatment

81

27,2 (17,9-38,2)

23,5 (14,8-24,2)

16,0 (8,8-25,9)

16,0 (8,8-25,9)

Psychological and pharmacological treatment

164

81,7 (74,9-87,3)

61,6 (53,7-69,1)

47,0 (39,1-54,9)

37,2 (29,8-45,1)

Nicotine replacement therapy

84

83,3 (73,6-90,6)

61,9 (50,7-72,3)

50,0 (38,9-61,1)

44,0 (33,2-55,3)

Bupropion

30

83,3 (65,3-94,4)

70,0 (50,6-85,3)

50,0 (31,3-68,7)

36,7 (19,9-53,9)

Varenicline

50

78,0 (64,0-88,5)

56,0 (41,3-70,0)

40,0 (26,4-54,8)

26,0 (14,6-40,3)

Global
According to multicomponent programme

% (95% Confidence Interval)

ADICCIONES, 2015 VOL. 27 ISSUE 1

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Antnia Raich, Jose Maria Martnez-Snchez, Emili Marquilles, Ldia Rubio, Marcela Fu and Esteve Fernndez

Table 3.
Risk factors for relapse at 12 months. Bivariate analysis.
Abstinencea
n=75

Relapsesa
n=239

Raw OR (95% CI)

p value

50,7[12,0]

47,8[12,0]

0,98 (0,96-1,00)

0,068

Sex
Man
Woman

51 (26,3)
24 (20,0)

143 (73,7)
96 (80,0)

1b
1,43 (0,82-2,47)

0,205

Educational level
Primary
Secondary
University

35 (18,2)
23 (36,5)
16 (29,1)

157 (81,8)
40 (63,5)
39 (70,9)

1b
0,39 (0,21-0,73)
0,54 (0,27-1,08)

0,003
0,082

Living with smokers


No
Yes

47 (30,1)
28 (17,7)

109 (69,9)
130 (82,3)

1b
2,00 (1,18-3,41)

0,011

Years smoked
> 35
21-35
<= 20

32 (29,6)
31 (22,5)
12 (17,6)

76 (70,4)
107 (77,5)
56 (82,4)

1b
1,45 (0,82-2,58)
1,96 (0,93-4,15)

0,202
0,077

Fagerstrm Test
<4 Low
4-5 Medium
<= 6 High

7 (25,9)
24 (33,8)
44 (20,4)

20 (74,1)
47 (66,2)
172 (79,6)

1b
0,68 (0,25-1,85)
1,37 (0,54-3,44)

0,455
0,505

Psychiatric antecedents
No
Yes

36 (27,3)
39 (21,4)

96 (72,7)
143 (78,6)

1b
1,38 (0,82-2,32)

0,231

1 (1,4)
13 (16,0)
61 (37,2)

68 (98,6)
68 (84,0)
103 (62,8)

1b
0,08 (0,01-0,60)
0,02 (0,003-0,18)

0,015
< 0,001

37 (44,0)
11 (36,7)
13 (26,0)

47 (56,0)
19 (63,3)
37 (74,0)

1b
1,36 (0,58-3,21)
2,24 (1,04-4,81)

0,483
0,039

Mean age [standard deviation]

Multicomponent programme
Neither psychological nor pharmacological
treatment
Psychological treatment
Psychological and pharmacological treatment
Nicotine replacement therapy
Bupropion
Varenicline
a

Number of individuals (% of row). b Reference category


OR: Odds Ratio; 95% CI: 95% Confidence Interval .

Table 4.
Risk factors for relapse at 12 months.
Multivariate analysis.

secondary education, not living with smokers, and receiving


multicomponent therapy with psychological treatment
alone or in conjunction with pharmacological treatment
emerged as predictors of success (p<0.05). As regards
pharmacological treatments, nicotine replacement therapy
is found to be the best predictor of success, with significant
differences compared to varenicline, though not compared
to bupropion (Table 3).
In the multivariate analysis, the factors found to protect
against relapse were having a secondary or university
education, not living with smokers, and receiving some type
of smoking cessation treatment, be it psychological only or
psychological plus pharmacological (Table 4).

Adjusted OR (95% CI)

p value

Age

0,98 (0,96-1,01)

0,169

Sex
Man
Woman

1a
1,36 (0,69-2,66)

0,371

Educational level
Primary
Secondary
University

1a
0,36 (0,18-0,73)
0,41 (0,19-0,89)

0,005
0,024

Living with smokers


No
Yes

1a
2,03 (1,12-3,68)

0,020

1a
0,06 (0,01-0,51)

0,010

0,02 (0,003-0,17)

<0,001

Multicomponent programme
Neither psychological nor
pharmacological treatment
Psychological treatment
Psychological and
pharmacological treatment
a

OR: Odds Ratio; 95% CI: 95% Confidence Interval.

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Smoking cessation after 12 months with multi-component therapy

Discussion

does not reduce the weight of this variable. In the univariate


analysis we observed that it is only significant to have
secondary education, and that having a university education
does not attain statistical significance, even though this aspect
does emerge as significant in the multivariate analysis. This is
probably due to the fact that in the subgroup with university
education there is a higher proportion of young people, in
whom we already saw a greater tendency for relapse; therefore,
when we adjust for age, having a university education also
shows up as significant. Thus, educational level is significant
as a predictor of success in multicomponent therapy. Bearing
in mind that various studies have shown how people with
higher levels of education respond better to psychological
therapy of whatever kind (Haustein, 2004; Piper et al., 2010;
Siahpush, McNeill, Borland, & Fong, 2006), all of this would
be in support of the hypothesis that psychological aspects play
a relevant role in attempts to quit smoking (Likura, 2010).
Occupational or professional level was also analyzed,
though it only yielded significant differences in the first
and sixth months, and not at the 12-month follow-up.
Educational level is stable in adults, while the occupation
variable can show considerable instability over the course
of life (Belleudi et al., 2006), which would explain why the
former yields greater significance and more robust results
than the latter, as the previously-cited studies have also
shown (Fernndez et al., 2006; Yanez, Leiva, Gorreto, Estela,
Tejera, & Torrent, 2013).
Level of dependence presented differences in the results,
as observed in previous studies (Baer & Marlatt, 1991;
Fernndez et al., 1998), though these differences were only
significant at the one-month and three-month follow-ups.
This is probably due to the effect of the pharmacological
treatment. The Fagerstrm Test is a good indicator of the
smokers level of physical dependence, but it is not reliable
for measuring psychological dependence (Nern et al.,
2007). People with high levels of physical dependence are
those that most benefit from pharmacological treatment
(De Leon, Diaz, Bevona, Gurpegui, Jurado, GonzalezPinto, 2003). However, in the medium and long term after
the pharmacological treatment is finished, what could be
determining relapse is not so much the physical dependence
level as the degree of psychological dependence and
the capacity for developing relapse prevention strategies
(Hajek, Stead, West, Jarvis, Hartmann-Boyce, & Lancaster,
2013; Siahpush et al., 2006).
The majority of studies to date with psychiatric patients
(Killen et al., 2008) have found them to have more difficulty
giving up smoking and to present higher relapse rates. In
our study, however, no such differences were appreciated.
Various factors could explain this: first of all, the broad
concept of psychiatric antecedents we employed, considering
a patient to fall into this category if they had at any time in
their life received a psychiatric diagnosis and been treated,
and this covers a wide range of levels of severity. Secondly,

As a result of a multicomponent smoking cessation


programme, 1 in 4 smokers with high levels of dependence
remained abstinent at the 12-month follow-up. These results
are independent of sex, age, psychiatric antecedents or
smoker characteristics. On the other hand, social factors
such as educational level or living/not living with other
smokers did indeed influence the results of this type of
therapy. Furthermore, receiving multicomponent therapy
with or without pharmacological treatment clearly increases
the likelihood of success, though patients who also receive
pharmacological treatment achieve better abstinence rates.
The results obtained in this study raise a number of points
for discussion. Some of the findings are at odds with those of
previous research. Thus, for example, the abstinence rates
are somewhat lower than might be expected for a highintensity therapy, while aspects such as participants sex or
psychiatric antecedents, which in the majority of studies
affect the success of the treatment (Fernndez, Garca,
Schiaffino, Borrs, Nebot, & Segura, 2001; Nern et al.,
2007; Perkins & Scott, 2008; Piper et al., 2010) do not yield
differences in this respect in our study.
These low abstinence rates compared to those of other
studies (Becoa & Vazquez, 1998; Nern et al., 2007) may
be due to the fact that the sample is not from the general
population; indeed, it is highly selective: the study took place
in a hospital smoking cessation unit, with participants who
had failed in previous attempts to quit smoking, with high
levels of nicotine dependence and who had been referred
from other hospital departments because they presented
smoking addiction-related pathologies. Some authors refer
to such people as recalcitrant smokers (Wilson, Wakefield,
Owen, & Roberts, 1992). Moreover, the results were analyzed
on an intent-to-treat basis, which makes it difficult to
compare this study with previous ones that exclude those
patients who gave up after the first visit. We found no
differences between men and women at any of the followups or at the end of the treatment. Although some previous
studies refer to sex differences (Bjornson et al., 1995) in
success rates for smoking cessation, more recent studies
with populations in phase IV of smoking dependence report
no such differences (Villalb, Rodriguez-Sanz, Villegas,
Borrell, 2009; Wilson et al., 1992). The absence of sex
differences in our study may be attributable to this, or to the
intensive intervention involved in multicomponent therapy.
Although some studies have found a higher incidence
of relapse in women (Heatherton, Kozlowsky, Frecker, &
Fagerstrm, 1991), others report a substantial improvement
in womens results when psychological therapy is added to
pharmacological treatment (Nern & Jan, 2007) but this
is an aspect requiring further research.
Educational level is associated with success of the therapy,
as various studies have shown (Fernndez et al., 2001; Piper et
al., 2010), and the fact of receiving multicomponent therapy

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Antnia Raich, Jose Maria Martnez-Snchez, Emili Marquilles, Ldia Rubio, Marcela Fu and Esteve Fernndez

following psychological therapy after the third smokingfree month is effective for the maintenance of abstinence
(Hajek et al., 2013). Likewise, various reviews have shown
how group therapy, cognitive-behavioural therapy and
interventions with intensive follow-up are more efficacious
in the long term (Bauld et al., 2010; Hall, Humfleet, Muoz,
Reus, Robbins, Prochaska, 2009).
We observed a clear advantage of nicotine replacement
therapy compared to varenicline. Given that this was a
descriptive study, it should be borne in mind that there
may be bias in relation to the selection of pharmacological
options, since they were not assigned randomly; hence,
we cannot draw the kinds of causal conclusions that could
be drawn from a study with experimental design. These
differences may be due to the fact that greater efficacy of
varenicline for reducing symptoms of craving (Stapleton
et al., 2008) would hinder the learning of coping strategies
for craving on the part of these patients. This is why after
the end of the pharmacological treatment we see a higher
relapse rate. Since we are talking about patients with serious
difficulties for quitting smoking, there may be an influence
of poor ability to apply relapse-prevention strategies. If this
were indeed the case, nicotine replacement therapy would
emerge as the most appropriate pharmacological treatment
for multicomponent therapy interventions with these types
of patients, while varenicline would be more suitable for
patients who had not previously tried and failed to quit,
who would not be followed-up after the pharmacological
treatment, or who did not receive psychological treatment,
though this hypothesis would need to be tested with specially
designed studies.
It would be useful to analyze therapy adherence according
to the characteristics of participants who completed
the treatment, since this would provide information on
predictors of adherence to multicomponent therapy and
would help in the consideration of possible aspects to
improve with a view to increasing it.
The main limitation of the present study concerns the
time dimension. The fact of the sample being recruited over
a long period (9 years) means that socio-cultural variables
(e.g., legislative changes with regard to the prohibition of
smoking in public spaces, changes in societys perception of
the risks involved in smoking) could be having an effect that
we have not controlled for. Thus, it may be that the 2005
legislation restricting smoking in public had some influence
on peoples motivation to give up smoking. On the other
hand, though, the fact that the smokers in our sample had
homogeneous characteristics (high level of dependence,
many with previous pathologies, several attempts to quit)
brings some correctional elements, so that this aspect does
not influence the results as much as it would in a study with
the general population. Another limitation is not having
a record of the exact date of relapse, as this prevents us
from knowing whether a patient starts smoking again and

the fact that patients with schizophrenia or severe psychotic


disorders were directly excluded. Though perhaps the most
relevant factor is the environment in which the treatment
programme took place, since the smoking cessation unit is
part of the hospitals mental health department in which
patients receive psychiatric follow-up. We believe that this
may have led to greater adherence to the treatment and
the sessions, as well as better monitoring and adjustment
of the psychiatric treatment according to patients progress
towards giving up the habit, facilitated by the coordination
between the professionals at the smoking cessation unit
and the mental health department. Previous studies in
similar environments, indeed, have found higher rates
of smoking cessation in these types of patient (CepedaBenito et al., 2004; Fagerstrm & Aubin, 2009). Finally, it
is reasonable to think that the intensive treatment involved
in multicomponent therapy improves the results of these
patients, as some authors have already suggested (Brown et
al., 2001; Himelhoch & Daumit, 2003).
In the present study, multicomponent therapy with or
without pharmacological treatment improves abstinence
rates at the 12-month follow-up. If we focus on the 81 patients
that opted for psychological treatment only, we can observe
a substantial smoking cessation rate that reveals the effect of
psychological therapy even without its reinforcement with
pharmacological treatment, as also shown in several previous
studies (Killen et al., 2008). Given that the data were analyzed
on an intent-to-treat basis, the group of 81 participants that
received the therapy without pharmacological treatment
incudes patients who dropped out during the first phase of
the treatment, so that we may actually be underestimating
the results yielded by psychological therapy without
pharmacological treatment. Focusing on the differences
between abstinence at one month and at twelve months, it
can be seen that the psychological treatment only group
lost 11% of patients to relapse, while the psychological plus
pharmacological treatment group lost 44%. This leads us to
think that those who achieve abstinence in the first month
without pharmacological treatment are keener to maintain
their abstinence than those who achieve it with the help of
pharmacological treatment, though it would be necessary to
carry out more studies with experimental design to be able
to confirm this hypothesis.
As regards pharmacological treatments, it was found
that all of the play an important role in all phases of the
process (Hajek, Stead, West, Jarvis, Hartmann-Boyce, &
Lancaster, 2013; Tinich & Sadler, 2007). The results suggest
that pharmacological treatment increases the likelihood of
success in quitting smoking in the first three months, and
that once a period of abstinence has been attained, the
probability of maintaining abstinence in the medium and
long term increases substantially (PHS Guideline Update
Panel 2008). A study with experimental design in patients
with characteristics similar to those in our study showed that

ADICCIONES, 2015 VOL. 27 ISSUE 1

43

Smoking cessation after 12 months with multi-component therapy

Antnia Raich, Jose M. Martnez-Sanchez and Esteve


Fernndez received funding from the Instituto de Salud
Carlos III (RETICC, beca RD12/0036/0053) and the
Departament dEconomia i Coneixement de la Generalitat de
Catalunya (2009 SGR 192).
This work received the XVI Premi del Bages de Cincies
Mdiques (XVI Bages Prize for Medical Science), awarded by
the Acadmia de Ciencies Mdiques de Catalunya filial del Bages
and the Collegi Oficial de Metges de Barcelona.

therefore drops out of the programme, or first drops out


of the programme which in turn leads to smoking relapse.
An advantageous aspect of the study is the fact of its
using co-oximetry to confirm abstinence, as it gives much
greater validity to the results than if we had only the patientreported information.
The restricted geographical context of the study may seem
like a limitation, given that the whole sample is concentrated
in the same smoking cessation unit, which attends to a
population with particular socio-cultural characteristics and
served by a specific health-service structure, and this could
limit the generalization potential of the results. Nevertheless,
the population is a heterogeneous one in terms of sociocultural characteristics, since both rural and urban regions
are represented: Manresa is a city of over 70,000 inhabitants,
situated within the third ring of the Barcelona metropolitan
area and with an urban culture, while other parts of the
sample are drawn from regions of central Catalonia with
primarily rural socio-economic environments.
The fact of being a clinical study carried out in a real
and natural context, that it seeks the most appropriate
treatment according to the patients characteristics and
that the data analysis is carried out on an intent-to-treat
basis are relevant aspects of the present study, enabling
it to provide information that complements the results
obtained in clinical trials conducted in ideal conditions
(Brown et al., 2001; Garrison & Dugan, 2009; Tinich et
al., 2007). In sum, we believe that this study permits as to
contribute data on the effectiveness of multicomponent
therapy in the clinical context, with heavy smokers and in
a real environment.
The results obtained in the present study show how
multicomponent therapy facilitates smoking cessation at
one, three, six and twelve months. Socio-environmental
characteristics such as higher educational level and not
living with smokers predicted success in quitting smoking
through multicomponent therapy, but this was not the
case for other variables, such as sex, smoker characteristics
and personal psychiatric antecedents. The combination of
pharmacological and psychological treatment increased
success rates in the multicomponent therapy, and
psychological therapy alone also yielded positive results,
though they were more limited in this case. In the light
of these results, which require confirmation through
experimental studies with better control of other possible
determinants of dropout and success, we might consider
a more generalized application of this type of therapy,
especially with heavy or recalcitrant smokers.

Conflicts of interests
The authors declare that there are no conflicts of interests.

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